Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants: a Randomized Clinical Trial (ENACT+)

NCT05525585 NA ACTIVE_NOT_RECRUITING

In this proposed clinical trial, the investigators will randomize 80 very preterm (VPT) infants to receive either early (between day 4 and 7) or delayed (between day 10 and 14) fortification and determine if providing early protein supplementation through early fortification results in higher FFM-for-age z scores and more diversity in the gut microbiome.

Details

Lead sponsor	University of Alabama at Birmingham
Phase	NA
Status	ACTIVE_NOT_RECRUITING
Enrolment	80
Start date	2022-11-17
Completion	2026-05

Conditions

• Prematurity
• Light-For-Dates
• Enteral Feeding Intolerance

Interventions

• Early HMF
• Delayed HMF

Primary outcomes

• Fat-free mass(FFM)-for-age Z-score — Postnatal day 14 to 21
  Estimated by air displacement plethysmography

Countries

United States